Instrumentation Laboratory medical device recall: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99843
- Recall initiated
- Sep 3, 2026
- Classified by FDA
- Oct 9, 2026
- Posted in Enforcement Report
- Oct 21, 2026
- Recalling firm
- Instrumentation Laboratory
- Firm location
- Bedford, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Products in this event
- 2
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Sep 3, 2026. FDA classified it 36 days later, on Oct 9, 2026. This recall event covers 2 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore. Instrumentation Laboratory has 25 recalls in our records.
Recalled products (2)
Z-0001-2027 Class I Ongoing
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Codes / lots: Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
Quantity: 434 units
Z-0002-2027 Class I Ongoing
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Codes / lots: Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
Quantity: 1,414 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99843
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.